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Six months of hormone therapy added to modern dose-escalated radiotherapy roughly halves the chance the PSA comes back, at every radiation dose tested.
EORTC 22991 randomised 819 men, median age 70, of whom 74.8 percent were intermediate risk and 24.8 percent high risk, to radiotherapy alone or radiotherapy with 6 months of androgen suppression given as two 3-monthly depot injections of a luteinising hormone-releasing hormone agonist starting on the first day of radiotherapy. Each centre chose its radiation dose: 70, 74 or 78 Gy.
At a median 7.2 years and with 319 events, androgen suppression significantly improved biochemical disease-free survival, hazard ratio 0.52 (95 percent confidence interval 0.41 to 0.66, p<0.001), and clinical progression-free survival, hazard ratio 0.63 (0.48 to 0.84, p=0.001) with 205 events. Overall survival data were not mature at that analysis.
The exploratory analysis that matters clinically found no statistically significant interaction between the effect of androgen suppression and the radiation dose (heterogeneity p=0.79 for biochemical disease-free survival and p=0.66 for progression-free survival). Dose escalation does not remove the need for hormone therapy, which is the question the trial was designed to answer.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
819 randomised.
Numbers not yet public.
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Biochemical disease-free survivalprimary | Radiotherapy with 6 months of androgen suppression | 410 | - | 0.52 (0.41 to 0.66) | <0.001 | link |
| Radiotherapy alone | 409 | - | ||||
| Clinical progression-free survival | Radiotherapy with 6 months of androgen suppression | 410 | - | 0.63 (0.48 to 0.84) | 0.001 | link |
| Radiotherapy alone | 409 | - |
Shares EORTC 22863, DART 01/05 GICOR, Curative intent vs palliative intent, Androgen deprivation therapy (ADT).
Shares Biochemical recurrence (BCR), Curative intent vs palliative intent, Androgen deprivation therapy (ADT), Localised prostate cancer, intermediate risk.
Shares RTOG 94-08, EORTC 22863, DART 01/05 GICOR, Androgen deprivation therapy (ADT).
Shares EORTC 22863, Curative intent vs palliative intent, Androgen deprivation therapy (ADT), Localised prostate cancer, high and very high risk.
Shares Curative intent vs palliative intent, Androgen deprivation therapy (ADT), Localised prostate cancer, high and very high risk, Androgen deprivation & AR pathway inhibitors.
Shares Biochemical recurrence (BCR), EORTC, Localised prostate cancer, high and very high risk, IMRT / IGRT (modern external beam).
Shares Biochemical recurrence (BCR), Androgen deprivation therapy (ADT), Androgen deprivation & AR pathway inhibitors, IMRT / IGRT (modern external beam).
Shares Androgen deprivation therapy (ADT), Localised prostate cancer, high and very high risk, Androgen deprivation & AR pathway inhibitors, IMRT / IGRT (modern external beam).